InSitu Hip System 10-11-0003Recalls & reported problems
Nextstep Arthropedix, LLC · Femoral Stem, Size 3, Lateralized · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816127022104), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2019Fracture
REVISION SURGERY WAS CONDUCTED DUE TO AN UNRECOGNISED INTRAOPERATIVE FRACTURE DURING INITIAL IMPLANTATION. STEM AND HEAD WERE REVISED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8453972 ↗
Other Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented devices
- AcuMatch 142-32-27Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2 recalls0 reports
- Novation 140-36-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall8 reports
- G7 DEPTH GAUGE 110010717Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented54 reports
- Novation 140-32-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall2 reports
- Novation 142-32-61Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 140-36-54Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 142-28-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 148-32-51Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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